Associate Director, Regulatory Affairs (Fully Remote)

Zai Lab Limited; United States; Remote; USD 180,000 - 241,000; Full time

Benefits offered by this job

Equity compensation

Annual bonus

Benefits package

Job summary

Zai Lab Limited is a biopharmaceutical company with a global footprint, focusing on oncology, autoimmune, infectious and neurological disorders. The role reports to senior leadership and guides regulatory strategies for multiple programs in the US and globally.

We seek a seasoned regulatory affairs professional with 10+ years of industry experience, strong leadership, and a track record of successful INDs and submissions.

Qualifications

• Bachelor's degree in life sciences; 10+ years in biopharma regulatory affairs.
• Experience with INDs and supporting regulatory submissions preferred.
• Strong communication and collaboration skills in a global matrixed environment.

Responsibilities

• Prepare health authority meeting materials and responses.
• Provide day-to-day regulatory guidance to cross-functional teams.
• Ensure compliance with global regulations and internal standards.

Skills

Regulatory affairs

IND submissions

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

• Support clinical regulatory strategies under senior leadership.
• Plan and manage regulatory submissions for assigned programs.

Major Responsibilities:

• Prepare health authority meeting materials and responses.
• Provide day-to-day regulatory guidance to cross-functional teams.
• Ensure compliance with global regulations and internal standards.

Qualifications:

• Bachelor's degree in life sciences with 10+ years in biopharma regulatory affairs.
• Experience with INDs and supporting regulatory submissions preferred.
• Strong communication and collaboration skills in a global matrixed environment.

Additional Information:

• Pay range: $180k-$241k/year, plus bonus, equity, and benefits.
• Zai Lab is an equal opportunity employer committed to diversity and inclusion.

Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.